CAPA-003
Adverse Event Reporting Procedure
Version
v1.0
Effective Date
May 7, 2026
Classification
CONTROLLED DOCUMENT
Tier Level
Tier 2 — SOP/Plan
Author
Regulatory Affairs
Owner
Regulatory Affairs
ISO Clause
FDA MDR, EU MDR
Category
CAPA
FDA MDR and EU MDR vigilance reporting for serious adverse events and field safety corrective actions.
#adverse-event#mdr#vigilance#fda#eumdr
Regulatory Standards
ISO 13485:201621 CFR Part 820EU MDR 2017/745
Revision History
| Version | Date | Author | Description |
|---|---|---|---|
| v1.0 | May 7, 2026 | Regulatory Affairs | Initial release |